Feasibility of Applying Remote Ischemic Conditioning in Secondary Prevention in Patients With Minor Ischemic Stroke or Transient Ischemic Attack -A Single-arm Futility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 167
- 试验地点
- 4
- 主要终点
- Recurrent rate of ischemic stroke/transient ischemic stroke
研究概览
简要总结
This is a single-arm, open-labeled and phase II futility study. Application of Remote ischemic conditioning (RIC) as an adjunctive therapy to medication were involved in the study. The study is to test whether RIC is effective in preventing ischemic evens after a minor ischemic stroke/transient ischemic attack within 3 months and to explore the safety and compliance of chronic RIC. Medication strategy is based on physician's best judgement.
详细描述
This is a single-arm, open-labeled and phase II futility study. Application of Remote ischemic conditioning (RIC) as an adjunctive therapy to medication were involved in the study. RIC consisted of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on bilateral upper limbs twice a day. The study is to test whether RIC is effective in preventing ischemic evens after a minor ischemic stroke/transient ischemic attack within 3 months and to explore the safety and compliance of chronic RIC. Medication strategy is based on physician's best judgement.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eighteen years old or older of any gender or race;
- •Diagnosed with a non-cardiogenic MIS/TIA within 14 days; MIS is defined by an ischemic stroke of score of 3 or less on the NIHSS at the time of inclusion, TIA is defined as neurologic deficit attributed to focal brain ischemia, with symptoms resolution within 24 h of symptom onset, Symptom onset is defined by the "last see normal" principle;
- •Stable vital signs, normal cardiac, hepatic and renal functions;
- •Able to consent by himself/herself or by legally authorized representative.
排除标准
- •Diagnosis of hemorrhage or other pathology, such as vascular malformation, tumor, abscess or other non-vascular diseases, based on brain CT or MRI;
- •Modified Rankin Scale score > 2 at inclusion;
- •Received iv. recombinant tissue plasminogen activator (rtPA) therapy or interventional treatment for the current event;
- •Contradiction for aspirin or clopidogrel (known allergy, severe asthma or heart failure et al.) ;
- •Clear indication for anticoagulation therapy ( cardiac source of embolus);
- •Hemorrhagic tendency of any reason （including but not limit to Hemostatic disorder, platelet count <100 × 109/L, history of drug-induced hepatic dysfunction）;
- •Any hemorrhagic transformation;
- •Gastrointestinal bleed or major surgery within 3 months of symptoms onset;
- •Stroke or TIA induced by interventional therapy or surgery;
- •Any upper extremity soft tissue, vascular injury or peripheral blood vessel disease which may contraindicate RIC;
- •Systolic blood pressure greater than 200 mmHg after medication;
- •Planned revascularization (any angioplasty or vascular surgery) within the next 3 months ；
- •Scheduled for surgery or interventional treatment requiring RIC cessation within next 3 months;
- •Severe noncardiovascular comorbidity with life expectancy < 3 months;
- •Currently receiving an investigational drug or device by other studies.
研究组 & 干预措施
Remote Ischemic Conditioning
RIC (remote ischemic conditioning) consists of five cycles of 5-min inflation (200 mmHg) and 5-min deflation of cuff on bilateral upper limbs twice a day. Medication strategy is based on physician's best judgement.
干预措施: Remote Ischemic Conditioning (Device)
结局指标
主要结局
Recurrent rate of ischemic stroke/transient ischemic stroke
时间窗: within 3 months
次要结局
- Treatment-Related Adverse Events(within 3 months)
- Compliance of remote ischemic conditioning(within 3 months)
- Incidence rate of vascular events(within 3 months)
- Improvements in NIH Stroke Scale(within1, 3 months)
- Improvements in modified Rankin Scale(within 1, 3 months)
- Improvements in Barthel Scale(within 1,3 months)
研究者
Ji Xunming
Professor, Chief Surgeon, Vice President
Capital Medical University